BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    VIATORR ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SL-PLUS LATERALIZED STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BELLEGLASS HP MODELING GEL

    FDA 510(k)
    FDA Class 2 ·Dental

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

    FOLYSIL SILICONE CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·August 28, 2024

    RADIESSE INJECTABLE IMPLANT

    FDA Adverse Event
    Injury ·MERZ NORTH AMERICA, INC·Product code LMH·July 24, 2024

    FOLYSIL SILICONE CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·August 28, 2024

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 27, 2013

    LMA UNIQUE

    FDA Adverse Event
    Malfunction ·THE LARYNGEAL MASK COMPANY LIMITED·Product code CAE·March 16, 2011

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·March 26, 2008

    PROTEGO PROMRI S 65

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·November 18, 2024

    FOLYSIL SILICONE CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·August 23, 2024

    FOLYSIL SILICONE CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·September 19, 2024

    FOLYSIL SILICONE CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·August 27, 2024

    SMR REVERSE HUMERAL BODY

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code PHX·May 12, 2023

    FOLYSIL SILICONE CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·December 19, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016